FDA Law Blog

OCTOBER 3, 2022

district court of Massachusetts by former employee and whistleblower Michael Bawduniak in April 2012 as a qui tam action. HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic. See United States ex rel.

Consulting 105

Consulting Healthcare Professional Government Specialization 105

The Clinical Problem Solvers

MARCH 14, 2025

These programs recognize the increasing difficulties in having to first see a community-based primary care provider before seeing a specialized psychiatrist. Suicide Trends Among Elementary School-Aged Children in the United States From 1993 to 2012. JAMA Netw Open. 2020;3(8):e2013100. doi:10.1001/jamanetworkopen.2020.13100

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

FDA Law Blog

AUGUST 18, 2024

The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. The classification order identifies the special controls and therefore is extremely important.

Specialization 69

Specialization Hospital Physicals Provider 69

FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature).

Patients 52

Patients Patient-Centered Clinic IT 52

Canadian Family Physician

FEBRUARY 18, 2025

Participants Older adults who are 65 years of age or older with advanced CKD and undergoing community-based nondialysis kidney care between April 1, 2012, and April 1, 2022, with at least 1 year of follow-up.

Primary Care 52

Primary Care Hospital Electronics Consulting 52

PEMBlog

MAY 24, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. 2012 Jan;109(3):27-32. 2012 Feb;13(1):35-40. These articles will take another look at the content included in this episode. Deaths due to physical restraint. Dtsch Arztebl Int. PMC3272587. Coburn VA, Mycyk MB. doi: 10.1016/j.emc.2009.07.003.

Management 54

Management Patient-Centered Physicals Finance 54

FDA Law Blog

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59